Cleared Traditional

K912122 - CHOLANGIOGRAPHY CATHETER

K912122 is an FDA 510(k) clearance for CHOLANGIOGRAPHY CATHETER, manufactured by Wiltek Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K912122 · Wiltek Medical, Inc. · Gastroenterology & Urology device
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Sep 1991
Decision
132d
Days
Class 2
Risk

K912122 is an FDA 510(k) clearance for the CHOLANGIOGRAPHY CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Wiltek Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wiltek Medical, Inc. devices

FDA 510(k) Submission Details - K912122

510(k) Number K912122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1991
Decision Date September 23, 1991
Days to Decision 132 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 130d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGE Stents, Drains And Dilators For The Biliary Ducts

All 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K912122.
DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT
K913073 · Biosearch Medical Products, Inc. · Oct 1991
2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH
K913841 · Endovations · Oct 1991
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON
K911630 · Baxter Healthcare Corp · Sep 1991
INTHERM RADIALLY EXPANDING DILATER
K912971 · Interventional Therapeutics Corp. · Sep 1991
DRAINAGE CATHETERS W/A DISSOLVABLE TIP
K900205 · Boston Scientific Corp · Aug 1991
BILIARY BALLOON DILATATION CATHETER
K910931 · Boston Scientific Corp · Apr 1991